Phil Borman

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.

A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

This downloadable Failure Mode Effect Analysis tool accompanies the article titled 'The Application of Quality by Design to Analytical Methods' by Phil Borman et. al.